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# Kite Labeling Update on Yescarta with Corticosteroids
- URL: https://www.fdaweb.com/kite-labeling-update-on-yescarta-with-corticosteroids/
- Published: 2022-02-01T12:00:00.000Z
- Updated: 2026-09-14T17:30:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151052

FDA has approved a Kite labeling update to the prescribing information for Yescarta (axicabtagene ciloleucel) to include use of prophylactic corticosteroids across all approved indications. Yescarta is now the only chimeric antigen receptor (CAR) T-cell therapy with information in the label to help physicians manage, and potentially prevent, treatment side effects. the company said.

Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy currently indicated for treating adult patients with relapsed or refractory large B-cell lymphoma and adult patients with relapsed or refractory follicular lymphoma.

The label update is based on data from a new safety management cohort (Cohort 6) of the pivotal ZUMA-1 study, which was designed to assess corticosteroids’ prophylactic impact and earlier treatment with corticosteroids and/or tocilizumab and prophylactic levetiracetam on the incidence and severity of cytokine release syndrome (CRS) and neurologic events, according to kite. In the cohort, no Grade 3 or higher CRS events occurred in patients taking corticosteroids.